Trial | NCT00355953  Report issue

Title

Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    genistein ...

  • Study Participants

    400
The present research program is proposed deepening some pharmacological effects of the genistein therapy in order to individualize alternative treatments to the conventional hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and the osteoporotic consequences in postmenopausal women.
Genistein is a phytoestrogen of the isoflavone family which has been shown to have beneficial effects on endothelial function and bone metabolism. On the basis of the so far obtained results, aim of our research was to investigate for a two years period the effects of genistein on cardiovascular risk factors, endothelial function and oxidative stress markers, bone metabolism and finally clarify pathophysiology mechanisms (by dosage of cytokines and endothelial markers) by which this molecule could interfere on atherosclerosis and bone mass loss progression.

Particularly, and in extreme synthesis the following parameters have been studied during the treatment:

inflammation markers as fibrinogen
lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, lipoprotein(a)-
endothelial function markers as VCAM-1 and ICAM-1
oxidative stress by the evaluation of the F(2)-isoprostane
cytokines as IL-6, OPG, RANK and RANKL
bone mineral density, by DEXA, at lumbar spine and femoral neck
Bone turnover markers as B-ALP, PYR, D-PYR
PAP-test, transvaginal uterine ecography and mammography.
Study Started
Jan 31
2003
Study Completion
Jun 30
2005
Last Update
Apr 22
2008
Estimate

Drug Genistein

Criteria 

Inclusion Criteria:

At least one year of menopause
No use of hormone replacement therapy
Bone mineral density T-score at the femoral neck minor than one S.D.

Exclusion Criteria:

Concomitant disease
Smoke habit
No Results Posted